Director, Medical Information

Posted 98ds ago

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Job Description

Director of Medical Information overseeing Medical Information function in clinical-stage biopharmaceutical company. Ensuring accurate dissemination of medical information and supporting pipeline assets and commercial products.

Responsibilities:

  • Defines and executes the global Medical Information strategy aligned with Medical Affairs and company objectives. This includes ownership of scientifically accurate, balanced, current, and compliant medical response content such as standard response documents, FAQs, scientific letters, and medical information platforms.
  • Oversees intake, triage, and response to unsolicited medical inquiries, ensuring consistent, high-quality responses within defined service-level agreements. The Director serves as the escalation point for complex or high-impact inquiries and ensures appropriate documentation and governance.
  • Leads Medical Information readiness for pre-launch and launch activities, including infrastructure development, staffing or vendor resourcing, content creation, training, and system readiness.
  • Builds and manages a high-performing Medical Information Call Center. This includes vendor oversight, quality assurance, budget management, and performance metrics and KPIs.
  • Supports scientific exchange at medical congresses, responding to health care provider inquiries at company-sponsored booths.
  • Provides Medical review of company materials in MLR review to ensure scientific accuracy, evidentiary support, and alignment with approved labeling.
  • Collaborates cross-functionally with Clinical Development, Regulatory Affairs, Pharmacovigilance/Safety, Legal, Compliance, Commercial, Market Access, and Manufacturing to enable appropriate scientific exchange and maintain separation of promotional and non-promotional activities.
  • Strategically supports Field Medical teams, including MSL training and content development.
  • Incorporates emerging clinical data, publications, congress insights, and real-world evidence into Medical Information content, with focus on complex and specialty therapies such as cell and gene therapies.
  • Ensures inspection readiness and supports audits, responses, and corrective actions related to Medical Information activities.

Requirements:

  • Advanced scientific or medical degree is required, such as PharmD, PhD, MD, or equivalent.
  • A minimum of 12 years of experience in Medical Information, Medical Affairs, or related scientific roles within the pharmaceutical or biotechnology industry is required, along with demonstrated leadership experience managing teams and/or outsourced Medical Information operations.
  • Deep knowledge of Medical Information regulations and compliance standards, including FDA, EMA, and applicable global guidance. Experience supporting pre-commercial and launch-phase organizations, as well as product launches and lifecycle management in regulated environments, is required.
  • Experience with complex or specialty therapies is strongly preferred, including cell therapy, gene therapy, immunology, neurology, oncology, or rare disease. Prior experience building or scaling a Medical Information function in a growing biotech organization is highly desirable. Global or ex-US experience is a plus.
  • Excellent scientific communication skills, strong strategic thinking, and operational discipline. The ideal candidate will demonstrate sound judgment, credibility with senior leaders and external stakeholders, and the ability to manage complexity in fast-paced, resource-conscious environments.

Benefits:

  • eligible for an annual bonus
  • comprehensive benefits
  • participation in the Company’s stock option plan